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1、BRITISH STANDARD BS 3531-5.7: 1991 ISO 9714-1: 1991 Implants for osteosynthesis Part 5: Bone screws and auxiliary equipment Section 5.7 Specification for drill bits, taps and countersink cutters BS 3531-5.7:1991 This British Standard, having been prepared under the direction of the Health Care Stand
2、ards Policy Committee, was published under the authority of the Standards Board and comes into effect on 30 August 1991 BSI 10-1999 The following BSI references relate to the work on this standard: Committee reference HCC/22 Draft announced in BSI News August 1991 ISBN 0 580 19970 3 Committees respo
3、nsible for this British Standard The preparation of this British Standard was entrusted by the Health Care Standards Policy Committee to Technical Committee HCC/22, upon which the following bodies were represented: British Institute of Surgical Technologists British Investment Casting Trade Associat
4、ion British Medical Association British Orthopaedic Association British Steel Industry British Surgical Trades Association Department of Health Institute of Sterile Services Management Medical Sterile Products Association Ministry of Defence National Association of Theatre Nurses Royal College of Su
5、rgeons of England Royal Veterinary College Scottish Office Amendments issued since publication Amd. No.DateComments BS 3531-5.7:1991 BSI 10-1999i Contents Page Committees responsibleInside front cover National forewordii 1Scope1 2Normative references1 3Materials and mechanical properties1 4Dimension
6、s1 5Marking1 Annex A (informative) Interrelationship of International Standards dealing with bone screws, bone plates and relevant tools3 Annex B (informative) Bibliography: International Standards referred to in table of Annex A4 Figure 1 Countersink cutter1 Table 1 Dimensions of drill bits, taps a
7、nd countersink cutters2 Publication(s) referred toInside back cover BS 3531-5.7:1991 ii BSI 10-1999 National foreword This Section of BS 3531 has been prepared under the direction of the Health Care Standards Policy Committee. It is identical with ISO 9714-1:1991 “Orthopaedic drilling instruments Pa
8、rt 1: Drill bits, taps and countersink cutters”, published by the International Organization for Standardization (ISO). BS 3531-5 was first published in 1982 and gave requirements for particular types of bone screw, for taps, drills and screwdrivers, and for holes and slots in bone plates. The revis
9、ion of BS 3531-5 offered the opportunity to facilitate the implementation of published and forthcoming International Standards, and to separate, in different Parts of BS 3531, requirements for screws and auxiliary equipment from those for bone plates. Requirements for bone screws and their auxiliary
10、 equipment are retained in BS 3531-23, also published in Sections. BS 3531-5:1982 is withdrawn. The drill bits, taps and countersink cutters specified in this Section of BS 3531 are suitable for use with the screws specified in BS 3531-5.3. It is strongly recommended that the products specified in t
11、his Section of BS 3531 should be manufactured according to the recommendations given in the “Quality Systems for Orthopaedic Implants 1990 Good Manufacturing Practice”1). Product certification. Users of this British Standard are advised to consider the desirability of third party certification of pr
12、oduct conformity with this British Standard based on testing and continued surveillance, which may be coupled with assessment of a suppliers quality systems against the appropriate Part of BS 5750. Enquiries as to the availability of third party certification will be forwarded by BSI to the Associat
13、ion of Certification Bodies. If a third party certification scheme does not already exist, users should consider approaching an appropriate body from the list of Association members. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards
14、 are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, pages 1 to 4, an inside back cover and a back cover. This stand
15、ard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Cross-references International StandardCorresponding British Standard ISO 5835:1991BS 3531 Implants for osteosynthesis Section 5.3:1991 Specifi
16、cation for dimensions of screws having hexagonal drive connection, spherical under-surfaces and asymmetrical thread (Identical) ISO 7153-1:1983aBS 5194 Surgical instruments Part 1:1985 Specification for stainless steels (Technically equivalent) a This standard had been revised and published as ISO 7
17、153-1:1991. 1) Compiled by the Department of Health; published and available from Her Majestys Stationery Office, 49 High Holborn, London WC1 6HB for personal callers or by post from HMSO, PO Box 276, London SW8 5DT. BS 3531-5.7:1991 BSI 10-19991 1 Scope This part of ISO 9714 specifies materials and
18、 mechanical properties, dimensions and marking requirements for drill bits, taps and countersink cutters made of stainless steel for use in orthopaedic surgery with bone screws as specified in ISO 5835. NOTE 1The interrelationship of International Standards dealing with bone screws, bone plates and
19、relevant tools is shown for information in Annex A. NOTE 2At present only stainless steel has been considered as a material for manufacturing these instruments. Other materials and coatings may be included at a later revision. 2 Normative references The following standards contain provisions which,
20、through reference in this text, constitute provisions of this part of ISO 9714. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this part of ISO 9714 are encouraged to investigate the possibility of applying the
21、 most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 5835:1991, Implants for surgery Metal bone screws with hexagonal drive connection, spherical under-surface of head, asymmetrical thread Dimensions. ISO 71
22、53-1:1983, Instruments for surgery Metallic materials Part 1: Stainless steel. 3 Materials and mechanical properties Drill bits, taps and countersink cutters shall be made from metal complying with the requirements given in ISO 7153-1, reference letter of steel grade: D, H, I and R. 4 Dimensions 4.1
23、 Drill bits The diameter of the drill bit shall be as given in Table 1. The point angle shall be in the range 80 to 100. 4.2 Taps The core diameter and outside diameter shall be as given in Table 1. The thread form and pitch shall be that of the appropriate screw as specified in ISO 5835. 4.3 Counte
24、rsink cutters The diameter of the pin and cutter head shall be as given in Table 1 and Figure 1. The cutter shall be either of conical form with an angle of 90 or of spherical form. 5 Marking 5.1 Drill bits Drill bits shall be marked with the diameter of the bit, expressed in millimetres. 5.2 Taps T
25、aps shall be marked with the code and nominal size of the screw, as specified in ISO 5835, with which they are intended to be used. 5.3 Countersink cutters Countersink cutters shall be marked with the nominal sizes of the screw, as specified in ISO 5835, with which they are Intended to be used. Figu
26、re 1 Countersink cutter BS 3531-5.7:1991 2 BSI 10-1999 Table 1 Dimensions of drill bits, taps and countersink cutters Dimensions in millimetres Screws (These data are extracted from ISO 5835 and are given here for information.) Drill bitsTapsaCountersink cutters ISO 5835 code Nominal diameter Core d
27、iameter Pitch Diameter of drill intended for drilling clearance hole Diameter of drill intended for drilling pilot tapping hole Outside diameter Core diameter Pitch Pin diameter d1 Cutter head diameter d2 Screws with shallow thread: HA 1,5 HA 2 HA 2,7 HA 3,5 HA 4 HA 4,5 HA 5 1,5 2 2,7 3,5 4 4,5 5 1,
28、1 1,3 1,9 2,4 2,9 3 3,5 0,5 0,6 1 1,25 1,5 1,75 1,75 1,5 2 2,7 3,5 4 4,5 5 1,1 1,5 2 2,5 3 3,2 3,7 1,5 2 2,7 3,5 4 4,5 5 1,1 1,3 1,9 2,4 2,9 3 3,5 0,5 0,6 1 1,25 1,5 1,75 1,75 1,1 1,1 2,5 2,5 2,5 4,5 4,5 4 4 6 6 6 8 8 Screws with deep thread: HB 4 HB 6,5 4 6,5 1,9 3 1,75 2,75 Not applicable to HB sc
29、rews 2 3,2 4 6,5 1,9 3 1,75 2,75 Not required for HB screws a It is recommended that the maximum variation from the theoretical profile at any point on thread form should not exceed: 0,050 mm for HA 1,5 and HA 2 0,075 mm for HA 2,7 to HA 5 0,075 mm for HB 4 and HB 6,5 0 0,02 0 0,02 0 0,15 0 0,15 0 0
30、,1 BS 3531-5.7:1991 BSI 10-19993 Annex A (informative) Interrelationship of International Standards dealing with bone screws, bone plates and relevant tools It has been decided that the set of International Standards dealing with bone screws, bone plates and relevant tools should be divided into two
31、 parallel series. The basis of the division into two series is the essentially different designs of the screw threads of the bone screws (HA and HB type screws as opposed to HC and HD type screws). A simplified schematic guide illustrating the interrelationship between screws, plates and tools cover
32、ed by the parallel series of International Standards is given on the following page. Screws Thread Head under-surface Drive connection ISO 5835ISO 9268 Mechanical requirements ISO 6475 Breaking torque/ angle of rotation In preparation Plates Holes and slotsISO 5836ISO 9269 Mechanical requirementsISO
33、 9585ISO 9585 Driving tools Keys and screwdrivers ISO 8319-1ISO 8319-2 Drill bits, taps, countersink cutters ISO 9714-1In preparation BS 3531-5.7:1991 4 BSI 10-1999 Annex B (informative) Bibliography: International Standards referred to in table in Annex A 1 ISO 5835:1991, Implants for surgery Metal
34、 bone screws with hexagonal drive connection, spherical under-surface of head, asymmetrical thread Dimensions. 2 ISO 5836:1988, Implants for surgery Metal bone plates Holes corresponding to screws with asymmetrical thread and spherical under-surface. 3 ISO 6475:1989, Implants for surgery Metal bone
35、screws with asymmetrical thread and spherical under-surface Mechanical requirements and test methods. 4 ISO 8319-1:1986, Orthopaedic instruments Drive connections Part 1: Keys for use with screws with hexagon socket heads. 5 ISO 8319-2:1986, Orthopaedic instruments Drive connections Part 2: Screwdri
36、vers for single slot head screws, screws with cruciate slot and cross-recessed head screws. 6 ISO 9268:1988, Implants for surgery Metal bone screws with conical under-surface of head Dimensions. 7 ISO 9269:1988, Implants for surgery Metal bone plates Holes and slots corresponding to screws with coni
37、cal under-surface. 8 ISO 9585:1990, Implants for surgery Determination of bending strength and stiffness of bone plates. 9 ISO 9714-1:1991, Orthopaedic drilling instruments Part 1: Drill bits, taps and countersink cutters. BS 3531-5.7:1991 BSI 10-1999 Publication(s) referred to See national foreword
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